Effect of Recombinant Human Brain Natriuretic Peptide on Ventricular Remodeling and Cardiac Function in Patients With Acute Anterior Myocardial Infraction Undergoing Percutaneous Coronary Intervention

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

This study is designed to evaluate the efficacy and safety of Recombinant Human Brain Natriuretic Peptide (rhBNP) in improving ventricular remodeling and cardiac function after acute anterior myocardial infarction undergoing percutaneous coronary intervention. 100 patients with acute anterior myocardial infarction after primary Percutaneous Coronary Intervention (pPCI) are randomly assigned 1:1 to rhBNP group(n=50) and control group(n=50) with follow-up of 24 weeks. Both groups are treated with standard therapy of AAMI, with the rhBNP group intravenous dripping rhBNP after pPCI for 3 days and the control group treated with placebo at the same time. The primary endpoint is the change in N terminal pro-B-type natriuretic peptide(NT-proBNP )and cardiac troponin T(cTnT) level.The secondary endpoint is the change in 24-week echocardiographic including left ventricle ejection fraction (LVEF) , left ventricular end-diastolic volume index (LVEDVI) and left ventricular end-systolic volume index (LVESVI), arrhythmia and cardiovascular events (death, cardiac arrest or cardiopulmonary resuscitation, hospitalization due to heart failure or angina pectoris).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The first acute anterior myocardial infarction ( AMI ) within 12 hours ( or more than 12 hours but the ischemic symptoms continue ).

Age 18-75 years old, gender unlimited

Patients with acute anterior myocardial infarction undergoing emergency PCI within the effective time window

Successful reflow after interventional therapy ( TIMI = 3 ).

Disqualifiers

Patients with a history of coronary artery bypass grafting

Patients with cardiogenic shock

Patients with systolic blood pressure ( SBP ) ≤ 90 mmHg after treatment with vasopressors

Patients with mechanical complications ( ventricular septal perforation, mitral chordae rupture )

Trial population

People who are about 18 to 75 years old get the first acute anterior myocardial infarction ( AMI ) within 12 hours ( or more than 12 hours but the ischemic symptoms continue ) and undergo emergency PCI within the effective time window,after which the blood reflows ( TIMI = 3 ).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Recombinant Human Brain Natriuretic Peptide

    Drug

    we divide our subjects into two groups;one is required to take recombinant human brain natriuretic peptide,the other is not required to take recombinant human brain natriuretic peptide

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: patients who take Recombinant Human Brain Natriuretic Peptide1 intervention
Group B: patients who do not take Recombinant Human Brain Natriuretic Peptide0 interventions

Trial outcomes

Primary outcomes

1

ultrasonic cardiogram:left ventricle ejection fraction (LVEF)

LVEF refers to the percentage of stroke output to left ventricular end-diastolic

Time frame
from baseline to 6 months
2

ultrasonic cardiogram:left ventricular end-diastolic volume index (LVEDVI)

LVEDVI(ml/m2)=left ventricular end-diastolic volume(ml)/body surface area

Time frame
from baseline to 6 months
3

ultrasonic cardiogram:left ventricular end-systolic volume index (LVESVI)

LVESVI(ml/m2)=left ventricular end-systolic volume(ml)/body surface area

Time frame
from baseline to 6 months
4

N terminal pro-B-type natriuretic peptide(NT-proBNP )decline level

NT-proBNP is a protein which is an "ingredient" for making the BNP hormone and a sign of heart failure can be obteined by blood

Time frame
from baseline to 6 months

Secondary outcomes

1

Adverse cardiovascular events

Time frame
from baseline to 6 months

Other outcomes

Sponsors and contacts

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